Nita A. Farahany, PhD, JD, is the Director of Science and Society and Professor of Law and Philosophy at Duke University. She was appointed in 2010 to the Presidential Commission for the Study of Bioethical Issues and continues to serve as a member.

GeneWatch: The technology we're discussing - "nuclear genome transfer," or "mitochondrial transfer," or "mitochondrial replacement," or "three-parent babies," whatever you prefer to call it ... actually, first off, what do you prefer to call it?

Nita Farahany: That would depend on which technique we're talking about. I don't ever use "three-parent babies," because that's just wrong. It takes far more to be a "parent" than mere contribution of mitochondrial DNA. "Mitochondrial transfer" is a more general term, which captures some of the different techniques.

You've talked about the need for adequate regulation of these technologies, but it seems safe to say you're also an advocate of moving forward with it. What sort of ethical or regulatory framework do you think is needed before the technology can be adopted?

I wouldn't say I'm an "advocate" for anything. I think that the process that the HFEA (the UK's Human Fertilisation and Embryology Authority) used to study the safety and efficacy of mitochondrial transfer was a pretty comprehensive approach to understanding the scientific issues. And safety and efficacy are ethical issues and independent criteria to consider. From a safety perspective, I think the data justifies moving to very small-scale clinical trials. But I'd want very careful oversight and follow-up of those trials.

I'd want to make sure that we carefully think about research participant selection, agreements about longer-term follow-ups so that we can be able to see what happens later on. And we would have to think about some of the possibilities that have been raised - for example, if all of this is done using an IVF procedure, whether or not selecting for male embryos in the first generation makes sense, because then you don't have the same concerns about the implications for future generations as far as passing on mitochondrial DNA. So I think we'd want to think very carefully about how we structure those studies, but we're at a stage where the data is strong enough to move toward determining how to best structure small-scale clinical trials.

Since there haven't been human clinical trials yet, so far the safety studies have been on rhesus monkeys - is that right?

Yes, and also mice.

And you don't think more is needed before moving to human clinical trials?

With any reproductive technology, for some people there will never enough data to justify a move to human clinical trials. And yet, we have as much if not more data than we did when we moved to human clinical trials for IVF. I think we're ready, particularly given the gravity of the consequences from not moving forward, to move to small-scale clinical trials.

Different regulatory bodies around the world have chosen different places to draw the line on what should and shouldn't be allowed as far as technologies that could result in human germline modification. Where would you draw the line?

I'm comfortable with mitochondrial transfer at this stage, but I would draw the line and say that we shouldn't be doing nuclear modification. Some of the data shows that with mitochondrial replacement, some of the mitochondrial abnormalities are actually coded within the nucleus, so the procedure might be more successful if it included nuclear changes. Nevertheless, I would limit it, at least right now, to only making mitochondrial transfer and not actually making nuclear changes.

You say you'd limit it "right now" - is there something that might change that?

I could imagine at some point in the distant future we might consider nuclear modifications as well, it's just not something that's anywhere close to being on the table.

So your concerns about modifying nuclear DNA are more about the science than about ethics?

I don't think it makes sense to draw bright lines between the science and the ethics. Good science is responsible science, so they go hand in hand. Scientifically, we're nowhere close to being able to reliably make nuclear modifications. I think for that reason, and for additional ethical concerns, staying out of nuclear modifications for now is the right approach. Could I imagine a future in which there were some nuclear modifications that we permitted? I could imagine such a future, but a lot of things would have to change between now and then.

In the meantime, with "mitochondrial transfer" - these technologies that could help prevent mitochondrial disease - am I right in understanding that this could greatly reduce the chances of passing on mitochondrial disease, but would not be able to altogether eliminate mitochondrial disease without also modifying the nuclear DNA?

So, two things. One is: Some people don't have such a high degree of abnormality that it would require them to have mitochondrial transfer. Low levels of abnormality could still be carried on generation to generation, and that could end up with one generation being disproportionately affected - through no intervention on our part, right, just because a fact of nature is that some people have a mitochondrial abnormality, and it may get passed on in higher concentrations to some offspring rather than other offspring. So you're still going to have some mitochondrial abnormalities in the population.

As for the people who have some of the mitochondrial abnormality that arises from problems within the nuclear DNA, you're right: These techniques wouldn't eliminate that. They do bring it down sufficiently to a level where you don't see the kind of health consequences you would otherwise.

Some are uneasy with these technologies because of the possibility that it enables "designer babies" or a sort of eugenics. But as I understand it, you look at a technology like this as more a matter of individual choice.

I think one of the things people worry about with eugenics is state-sponsored eugenic action. That is very different from private individuals making private choices, which will vary from person to person. You know, not everyone chooses a child with blond hair and blue eyes, one reason being that many people want children who look like them. Of course, this is in the world of nuclear DNA modifications, which I think is far off. But imagining that future, if it's private individuals making private choices, it's going to lead to a much greater diversity of choices than we'd expect in a state-sponsored eugenic society. So I have less concern than some people do about dystopian eugenic futures, because I think that presupposes a very different approach to decisions about reproduction.

So in other words, the problem would be not the technology, but how it's used and how it's regulated?

I think technology is neither good nor evil; it's how we use it that determines its normative value. The same technology can be put to good or evil purposes. What I would feel comfortable with is enabling technology to proceed, but ensuring that we have a prudent approach to overseeing that technology to safeguard against misuse.